Evrysdi™ (risdiplam)
Genentech, a member of the Roche Group, of South San Francisco, Calif.
Product Images
Recalled prescription drug Evrysdi
Recalled prescription drug with press-in bottle adapter
Why is it being recalled? (Hazard)
The bottles containing the prescription drug can leak due to a fit issue between the press-in bottle adapter and bottleneck. If the bottle is leaking, there is a risk of drug exposure by contact with skin or eyes. Prescription drugs must be in child resistant packaging that prevents children from gaining access to the contents as required by the Poison Prevention Packaging Act (PPPA).
What should I do? (Remedy)
Consumers should immediately store Evrysdi in a safe location out of reach and sight of children. Consumers should inspect the bottle for any leaking. If it is leaking, contact Genentech for a free replacement. Consumers can continue to use as directed, as the leakage is not anticipated to impact the safety or efficacy of administered medicine. If Evrysdi gets on your skin, wash the area with soap and water. If Evrysdi gets in your eyes, rinse your eyes with water. Genentech is contacting all known purchasers directly.
Consumer Contact
Genentech at 800-334-0290 from 8 a.m. to 8 p.m. ET Monday through Friday or online at www.Evrysdi.com and click on the "leaking bottles safety information" banner on the homepage for more information.
Product Description
This recall involves bottles of the prescription drug Evrysdi, a prescription medicine used to treat spinal muscular atrophy (SMA) in adults and children 2 months of age and older. The recalled 100 mL amber bottles have "Evrysdi (risdiplam) for oral solution," the dosage and "NDC 20242-175-07" on the front of the bottle labels.
Where was it sold?
Select specialty pharmacies nationwide as a prescribed medicine from August 2020 through the present. The price of the medication varies based on health insurance terms and other factors.
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Quick Facts
Recall Number
21729
Impacted Units
About 14,000
Incidents/Injuries
Genentech has received 26 reports of leaking bottles. No injuries have been reported.
Did you buy this?
Stop using the product immediately. Check the "Remedy" section for refund or repair instructions.